Recall Z-0612-2020 ยท HWA Impactor
Enztec Limited
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
| Date | Jan 24, 2020 (initiated Aug 16, 2019) |
| Status | Terminated |
| Reason | The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery. |
| Root cause | Unknown/Undetermined by firm |
| Action | On August 16, 2019, a Urgent Medical device recall for Product Correction" letter was emailed to affected consignees. In addition to informing the consignees about the recall, the |
| Quantity | 312 Femoral Impactors |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.